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IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity (INSPIRE)

This study is currently recruiting participants.
Verified February 2017 by IRX Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02609386
First Posted: November 20, 2015
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
IRX Therapeutics
September 10, 2015
November 20, 2015
February 20, 2017
December 2015
February 2019   (Final data collection date for primary outcome measure)
Change in Event-Free Survival from baseline [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18, 21,24,30,36,42,48 months ]
To determine if the event-free survival (EFS) of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2
Same as current
Complete list of historical versions of study NCT02609386 on ClinicalTrials.gov Archive Site
  • Change in Overall Survival from baseline [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18,21,24,30,36,42,48 months ]
    To determine if OS of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2
  • Change in safety from baseline in each Regimen using a pre-approved questionnaire (case report form) [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18,21,24,30,36,42,48 months ]
    Medical professional will assess according to pre-specified list for patient response, lab results, adverse events, etc. at pre-specified intervals. Pain to be assessed using NCI Criteria grade from the following: None, Mild, Moderate or Severe
  • Change in tumor size from baseline to surgery [ Time Frame: Measured at time of pre-screening and at time of surgery (approx. 6-7 weeks) ]
    CT/MRI scan measurement, in cm.
  • Change in lymphocyte infiltrates in tumor comparing pre-treatment biopsy and surgical specimens [ Time Frame: Measured at time of pre-screening and at time of surgery (approx. 6-7 weeks) ]
    Computerized counting of lymphocyte infiltration
Same as current
Not Provided
Not Provided
 
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.

This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole.

The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs event-free survival and overall survival when compared to Regimen 2 without IRX-2.

Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Squamous Cell Carcinoma of the Oral Cavity
  • Biological: IRX-2
    Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
    Other Name: Immunotherapy
  • Drug: Cyclophosphamide
    Method of Administration: Cyclophosphamide is administered once by IV
    Other Names:
    • Cytophosphane
    • Cytoxan
  • Drug: Indomethacin
    Method of Administration: Indomethacin is administered orally for 21 days.
    Other Names:
    • NSAID
    • Indocin
  • Dietary Supplement: Zinc-containing multivitamin
    Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
    Other Names:
    • Zinc
    • Multi-vitamin
  • Drug: Omeprazole
    Method of Administration: Omeprazole is administered orally for 21 days
    Other Names:
    • Proton pump inhibitor
    • Prilosec
  • Experimental: Regimen 1
    IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy.
    Interventions:
    • Biological: IRX-2
    • Drug: Cyclophosphamide
    • Drug: Indomethacin
    • Dietary Supplement: Zinc-containing multivitamin
    • Drug: Omeprazole
  • Active Comparator: Regimen 2
    Regimen 1 but without IRX-2
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Indomethacin
    • Dietary Supplement: Zinc-containing multivitamin
    • Drug: Omeprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2019
February 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pathologically confirmed (histology or cytology) Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip)
  2. Disease surgically resectable with curative intent
  3. Hematological function: hemoglobin >9 g/dL; lymphocyte count >500 x 109/mL; neutrophil count >1500 x 109/mL; platelet count >100,000 x 109/mL
  4. Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <3x the upper limits of normal (ULN); alkaline phosphatase <2x the ULN
  5. Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
  6. Calculated creatinine clearance > 50 mL/minute (Appendix 3)
  7. At least 18 years of age
  8. Willing and able to give informed consent and adhere to protocol therapy
  9. Karnofsky performance status (KPS) >=70%
  10. Able and willing to use a medically acceptable form of pregnancy prevention
  11. Negative urine/serum pregnancy test, if applicable

Exclusion Criteria:

  1. Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
  2. Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
  3. Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
  4. Tumor of the oropharynx
  5. Other clinical issues that would make participation in this clinical trial inappropriate.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: IRX INSPIRE INSPIRE@IRXTherapeutics.com
United States
 
 
NCT02609386
IRX-2 2015-A
Yes
Not Provided
Not Provided
IRX Therapeutics
IRX Therapeutics
Not Provided
Principal Investigator: Gregory T Wolf, MD, FACS University of Michigan Hospitals
IRX Therapeutics
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP